Apparatus and methods for endoscopic suturing

ABSTRACT

Apparatus &amp; methods for endoscopic suturing are described herein. A distal tip of the endoscopic device engages the tissue and then approximates the engaged tissue to form a tissue fold. A needle body positioned within a flexible catheter is deployed into or through the newly created tissue fold where it is then detached or released from the endoscopic device. The needle body has a length of suture which depends therefrom and can be used to secure the tissue fold. The entire endoscopic device or its tissue engaging assembly can then be rotated relative to the tissue fold while maintaining engagement with the tissue to maneuver the flexible catheter to the opposing side of the penetrated tissue fold. This procedure can be repeated any number of times to create an interrupted, continuous, or running suture to secure the tissue fold.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.10/986,461, filed on Nov. 10, 2004, which claims the benefits ofpriority to U.S. Provisional Patent Application Ser. No. 60/519,881filed Nov. 13, 2003, the content of each of which is incorporated hereinby reference in its entirety.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to apparatus and methods forendoscopically forming and suturing tissue. More particularly, thepresent invention relates to apparatus and methods for endoscopicallyforming tissue folds and continuously suturing those folds.

Various devices and methods for grasping free ends or lengths of sutureand passing the suture material through tissue are known. One methodgenerally involves attaching a suture end to a needle and passing theneedle through the tissue using a needle manipulating device. Oncepassed through the tissue, another device is typically employed toretrieve or otherwise manipulate the needle and suture.

Other methods generally utilize sharpened needle tips which areconfigured to retain a suture. The needle tip is then able to penetratethe tissue and leave the suture end on the far side of the tissue whereit can be grasped for further manipulation. Such grasping mechanismsgenerally employ various configurations such as the use of wire-likehooking elements, looped wires, etc. Some devices employ suture graspingelements, such as forceps jaws, with sharpened tips to grasp and passthe suture material.

However, many of the conventional devices have limitations inapplications such as closed surgery, especially arthroscopic orlaparoscopic surgery, where space and visibility constraints at thesurgical site render it difficult to fully extend a suture graspingdevice to easily grasp a suture. Moreover, many of the devices areconstrained to regions within the body accessible via straight-lineaccess. This is typically due to the rigidity of the tool shaft uponwhich the graspers or needles are employed.

Furthermore, because of the typical size and rigidity of the tool, sucha suture passing instrument is typically inserted within a patient as aseparate tool which occupies valuable space. Additionally, other toolsare typically needed to facilitate the manipulation of the suturematerial through the tissue.

BRIEF SUMMARY OF THE INVENTION

In forming or securing folds of tissue, e.g., in the gastrointestinal(GI) tract such as the stomach of a patient, tissue folds may be formedto treat various conditions such as obesity. Such treatments may beeffected via an endoscopic device designed to engage a tissue wall,create one or more tissue folds, and secure the tissue fold(s) withtissue anchors and/or suture.

One such endoscopic device described herein may have a primary grasperat a distal tip of the endoscopic device configured to engage the tissueand then approximate the engaged tissue to a proximal position relativeto the catheter tip, thereby providing a uniform plication ofpredetermined size. A needle body detachably or removably positionedwithin a flexible catheter or launch tube may be deployed from thelaunch tube such that it passes at least partially within or entirelythrough the fold Formed by the approximated tissue. The needle body mayalso have a length of suture attached thereto for passage through thetissue fold. Once the needle body has been penetrated into or throughthe tissue fold, it may be detached or released from the endoscopicdevice via a secondary needle grasper. A description of one or moreendoscopic devices which may be utilized to initially form the one ormore tissue folds may be seen in further detail in U.S. patentapplication Ser. No. 10/735,030 filed Dec. 12, 2003, which isincorporated herein by reference in its entirety.

The needle body itself may generally be configured as a needle havingone or two tapered piercing ends on opposing sides of the needle body. Asuture attachment point, e.g., an eyelet or opening, may be definedalong the needle body and serve as an attachment point for a length ofsuture. Alternatively, an expandable anchor may also be positionedwithin a needle body for passage through tissue. Once free of thetissue, the anchor may be deployed from the needle body for placementagainst the tissue. Other variations of the needle body and grasper maybe seen in further detail in U.S. patent application Ser. No. 10/989,684filed Jul. 23, 2004, which is incorporated herein by reference in itsentirety.

In operation, once the needle body has been advanced through or at leastpartially through the tissue fold, the needle body may be released bythe secondary needle grasper and the entire endoscopic device or itstissue engaging assembly may then be rotated relative to the oppositeside of the tissue fold, i.e., on the side of the tissue where theneedle body exits the tissue fold, while maintaining engagement with thetissue via the primary grasper to maneuver the catheter or launch tubeto the opposing side of the penetrated tissue fold. The rotatableprimary grasper may keep its grasp on the tissue fold to maintain aposition of the device relative to the tissue fold and needle body. Thelength of suture remains attached to the needle body and is routedthrough the tissue passage created by the needle body.

The secondary grasper may then be used to grasp onto the needle body andwhile holding the needle body, the entire apparatus may again be rotatedto realign the needle launch tube back to the other side of the tissuefold. Once the needle body has been desirably positioned, it may againbe manipulated to align the catheter distal tip transversely relative tothe tissue fold which may again be pierced by advancing the needle bodyinto or through the tissue fold at another location adjacent to theoriginally formed tissue passage. This process may be repeated anynumber of times to form a continuous or running suture depending uponthe desired length of suture and the desired suturing effects.

Additionally, a gastroscope having a sufficiently small-sized diametermay be introduced into the area by advancing the gastroscope through alumen defined through the endoscopic device to provide endoscopicvisualization of the procedure. Alternatively, a gastroscope may be maybe attached or connected to a tubular member disposed externally of theendoscopic device. In another alternative, an imager may be directlyintegrated into the distal tip of the endoscopic device.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIGS. 1A and 1B show a side view and detail view, respectively, of onevariation of an endoscopic device for forming and suturing a tissue foldwithin a hollow body organ.

FIGS. 2A and 2B show side-sectional views of a tissue grasping assemblysuitable for use with the endoscopic device of FIGS. 1A and 1B.

FIGS. 3A to 3E show side views illustrating one example of a method forforming a tissue fold with the device of FIGS. 1A and 1B.

FIG. 4 shows another variation of the endoscopic device having arotatable tissue grasping assembly which may be used in creating acontinuous stitch in tissue.

FIGS. 5A to 5F show side views illustrating another example of a methodfor forming and suturing a tissue fold with a continuous running stitch.

FIGS. 6A and 6B show side views of an endoscopic device with alternativevariations for endoscopically visualizing a tissue folding and/orsuturing procedure.

FIG. 7 shows a perspective partial view of a resulting tissue fold whichwas secured via a continuous running stitch.

FIG. 8A shows a side view of a deployable anchor which may be positionedwithin a needle body for deployment against a tissue fold.

FIGS. 8B and 8C show one example of how an expandable anchor may bedeployed from a needle body passed through a tissue fold.

DETAILED DESCRIPTION OF THE INVENTION

Various methods and devices for forming and/or securing folds of tissue,e.g., in the gastrointestinal (GI) tract such as the stomach of apatient, are presented herein. Such tissue folds may be formed to treatvarious conditions, for example, for the treatment of obesity byapproximating the walls of a gastrointestinal lumen to narrow the lumenand thereby reduce the area for absorption in the stomach or intestines.Such treatments may be effected via an endoscopic device that engages atissue wall of the gastrointestinal lumen, creates one or more tissuefolds, and secures the tissue fold(s) with tissue anchors and/or suture.The suture is preferably disposed through the muscularis and/or serosalayers of the gastrointestinal tissue, as described in further detailbelow.

In operation, a distal tip of the endoscopic device engages the tissueand then approximates the engaged tissue to a proximal position relativeto the catheter tip, thereby providing a uniform plication ofpredetermined size. A needle body detachably or removably positionedwithin a flexible catheter or launch tube may be deployed from thelaunch tube such that it passes at least partially within or entirelythrough the fold Formed by the approximated tissue. The needle body mayalso have a length of suture attached thereto for passage through thetissue fold.

Once the needle body has been penetrated into or through the tissuefold, it may be detached or released from the endoscopic device. Theentire endoscopic device or its tissue engaging assembly may then berotated relative to the tissue fold while maintaining engagement withthe tissue to maneuver the catheter or launch tube to the opposing sideof the penetrated tissue fold.

Formation of a tissue fold may be accomplished using at least two tissuecontact areas that are separated by a linear or curvilinear distance,wherein the separation distance between the tissue contact pointsaffects the length and/or depth of the fold. In operation, a tissuegrabbing assembly engages or grasps the tissue wall in its normal state(i.e., non-folded and substantially flat), thus providing a first tissuecontact area. The first tissue contact area then is moved to a positionproximal of a second tissue contact area to form the tissue fold. Thetissue anchor assembly then may be extended across the tissue fold atthe second tissue contact area. Optionally, a third tissue contact pointmay be established such that, upon formation of the tissue fold, thesecond and third tissue contact areas are disposed on opposing sides ofthe tissue fold, thereby providing backside stabilization duringextension of the anchor assembly across the tissue fold From the secondtissue contact area.

Preferably, the first tissue contact point is used to engage and thenstretch or rotate the tissue wall over the second tissue contact pointto form the tissue fold. The tissue fold may then be approximated to aposition wherein a portion of the tissue fold overlies the second tissuecontact point at an orientation that is normal to the tissue fold. Aneedle body and suture may then be delivered across the tissue fold ator near the second tissue contact point. A description of one or moreendoscopic devices which may be utilized to initially form the one ormore tissue folds may be seen in further detail in U.S. patentapplication Ser. No. 10/735,030 filed Dec. 12, 2003, which isincorporated herein by reference in its entirety.

Referring to FIG. 1A, apparatus 10 generally comprises torqueablecatheter or tubular member 11 having distal region 12 from which a firstand a second flexible tube 13, 14, respectively, may extend. First andsecond tubes 13, 14 may be interconnected to one another along theirlengths and are preferably interconnected near their distal ends in apivoting manner, as described below. Proximal region 15 of apparatus 10may be operably connected to handle 16 and actuator 17, which mayactuate the distal region 12 of apparatus 10. Catheter or tubular member11 may generally be configured for insertion through a patient's mouthand esophagus into the gastrointestinal lumen. Tissue grabbing assembly18 is disposed on the distal end of flexible tube 13, and is operablycoupled to actuator 17 via one or more control wires 19 that extendthrough flexible tube 13. Tissue grabbing assembly 18 is shownillustratively as a grasper but may be configured in a variety of otheralternative tissue grasping assemblies.

As better illustrated in FIG. 1B, flexible tubes 13 and 14 may beconnected via hinge assembly 20 that comprises link 21 attached toflexible tube 13 at pivot point 22 and attached to flexible tube 14 atpivot point 23. Hinge assembly 20 may be configured to prevent tissuegrabbing assembly 18 from moving more than a predetermined distancerelative to distal end 24 of flexible tube 14.

Flexible tubes 13 and 14 preferably include bendable sections 25 and 26,respectively. The bendable sections 25 and 26 may comprise, for example,a plurality of through-wall slots 27 to enhance flexibility of the tube.Preferably, flexible tubes 13 and 14 are made from polymeric materialsor biocompatible metals such as nitinol or stainless steel with anetched or laser-cut slot pattern. The through-wall slots 27 may beconfigured as a sinusoidal repeating pattern of slots perpendicularlydefined relative to the longitudinal axis of tubes 13 and 14.Alternative flexible patterns will be apparent to those of skill in theart.

referring to FIGS. 2A and 2B, tissue grabbing assembly 18 may comprisesa pair of jaws 28 a, 28 b arranged to rotate about pivot point 29between an open configuration (FIG. 2A) and a closed configuration (FIG.2B). One or more control wires, shown here as a single control wire 19,is coupled via pivot point 30 to arms 31 a and 31 b. Arms 31 a and 31 bare in turn pivotally coupled to jaws 28 a and 28 b, respectively, atpivot points 32 a and 32 b. Each of jaws 28 a and 28 b may includesharpened teeth 33 or protrusions disposed near its distal ends tofacilitate grasping of the tissue wall of the GI lumen.

Control wire 19 is coupled to actuator 17 of handle 16 so thattranslation of the wire 19 within flexible tube 13 causes the jaws 28 a,28 b to open or close. In particular, urging control wire 19 distally(as indicated by arrow A in FIG. 2A) moves pivot point 30 distally,thereby forcing the jaws 28 a, 28 b to open. Urging control wire 19proximally (as indicated by arrow b in FIG. 2B) moves pivot point 30proximally, thereby forcing the jaws 28 a, 28 b to close together. Inalternative variations, tissue grabbing assembly 18 may comprise, e.g.,a corkscrew, suction ports, grappling hook or fork, a plurality ofneedles coupled to the distal end of flexible tube 13, etc.

Flexible tube 14 may be affixed to and immovable within catheter 11,while flexible tube 13 is coupled to catheter 11 via hinge 20.Accordingly, when control wire 19 is extended in the distal direction,flexible tube 13 is carried in the distal direction. When control wire19 is retracted in the proximal direction, flexible tube remainsstationary until jaws 28 a and 28 b close together, after which furtherretraction of control wire 19 by moving actuator 17 causes flexible tube13 to buckle in bendable region 25, as described below.

Referring now to FIGS. 1 and 3 a-3 e, operation of apparatus 10 isdescribed for creating a tissue fold in a tissue wall of a GI lumen. InFIG. 3A, distal region 12 of catheter 11 is positioned within apatient's GI lumen transesophageally, and jaws 28 a and 28 b of tissuegrabbing assembly 18 are opened by moving actuator 17 to the distal-mostposition on handle 16. As depicted in FIG. 3B, actuator 17 may then bemoved proximally until the jaws of tissue grabbing assembly 18 engage aportion of tissue wall w at contact point P1.

Referring to FIG. 3C, after the tissue wall w has been engaged atcontact point PI, flexible tube 13 is urged proximally within catheter11 by further proximal retraction of control wire 19 to stretch tissuewall w and create tissue fold F. During this movement of flexible tube13, link 21 of hinge assembly 20 causes tissue grabbing assembly 18 tomove from a position distal to distal end 24 of flexible tube 14, to aposition proximal of distal end 24 of flexible tube 14. Bendablesections 25 and 26 of flexible tubes 13 and 14, respectively, mayaccommodate any lateral motion caused by operation of hinge assembly 20.Advantageously, formation of fold F facilitates the penetration of thetissue wall w by a needle and subsequent delivery of an anchor assemblyor passage of a length of suture, as described hereinafter.

Referring to FIG. 3D, additional proximal movement of actuator 17 causesflexible tubes 13 and 14 to buckle at bendable sections 25 and 26. Hingeassembly 20 transmits force applied to flexible tube 13 via control wire19 and actuator 17 to the distal tip 24. Preferably, flexible tube 14 isconfigured so that distal tip 24 contacts, and is generallyperpendicular to tissue fold F at contact point P2. As illustrated inFIG. 3E, once tissue fold F is stretched across distal tip 24 offlexible tube 14, sharpened needle or obturator 34 may be extended fromdistal tip 24 of flexible tube 14 to pierce all four layers of thetissue wall w. Sharpened needle or obturator 34 is inserted via inlet 35to flexible tube 14 on handle 16 (see FIG. 1A).

As discussed above, the GI lumen comprises an inner mucosal layer,connective tissue, the muscularis layer and the serosa layer. To obtaina durable purchase, e.g., in performing a stomach reduction procedure,the staples or anchors used to achieve reduction of the GI lumenpreferably engage at least the muscularis tissue layer, and morepreferably, the serosa layer as well. Advantageously, stretching oftissue fold F across distal tip 24 permits an anchor or length of sutureto be ejected through both the muscularis and serosa layers, thusenabling durable gastrointestinal tissue approximation.

As depicted in FIG. 3E, after tissue fold F is stretched across distaltip 24 of flexible tube 14 to form contact point P2 with tissue wall w,needle 34 may be extended from distal tip 24 and through tissue fold F.Because needle 34 penetrates the tissue wall twice, it exits within theGI lumen, thus reducing the potential for injury to surrounding organs.Once the needle has penetrated tissue fold F, an anchor assembly orlength of suture may be ejected through distal tip 24. The deployment ofanchors through needle 34 as well as other variations of the apparatus10 may be seen in further detail in U.S. patent application Ser. No.10/735,030 which has been incorporated herein by reference above.

The apparatus 10, as described above, may be further utilized insuturing the newly formed tissue fold F in an interrupted, continuous,or running suture depending upon the length of the newly formed tissuefold and the desired method of tissue fold securement. As shown in thedetail assembly view of FIG. 4, jaw assembly 36 and jaw members 28 a, 28b may be freely rotatable about its longitudinal axis relative toflexible tube 13 and catheter tube 11, as indicated by the arrow c.Moreover, a secondary grasper assembly 37 having a secondary grasper 39on a distal end of tubular member 38 may be slidably positioned withinflexible tube 14. Grasper 39 may be articulated between an open andclose configuration from its proximal end preferably located withinhandle 16.

Grasper 39 may generally comprise a variety of graspers but ispreferably configured to grasp and hold onto a needle such as needlebody 40. As shown illustratively in FIG. 4, needle body 40 may generallybe configured as a needle having one or two tapered piercing ends onopposing sides of needle body 40. A suture attachment point 41, e.g., aneyelet or opening, may be defined along needle body 40 and serve as anattachment point for a length of suture 42.

Grasper 39 and flexible tube 38 may define a passage or lumen throughwhich needle body 40 may be passed. Alternatively, grasper 39 andflexible tube 38 may be configured to retain needle body 40 at leastpartially therein and grasper 39 may be at least partially retractedwithin flexible tube 14 by the proximal translation of flexible tube 38.As mentioned above, needle body 40 may be configured in a variety ofways, e.g., a needle body having a piercing tapered end and a balledproximal end to facilitate grasping of the needle body. Other variationsof the needle body 40 and grasper 39 may be seen in further detail inU.S. patent application Ser. No. 10/989,684 filed Jul. 23, 2004, whichis incorporated herein by reference in its entirety.

In operation, the tissue wall w may be grasped and approximated andflexible tube 14 may be curved to align distal tip 24 transverselyrelative to the tissue fold F, as described above. However, in thisvariation and as shown in FIG. 5A, needle body 40 may be advanced andpierced into and/or through tissue fold F via grasper 39 being advanceddistally through flexible tube 14. The tissue wall w is shown in thisand the following figures as having at least a mucosa layer MUC and anunderlying muscularis layer MUS as typically found in hollow body organssuch as the stomach, although the device and methods are not limited touse in only the GI tract of a patient.

as seen in FIG. 5B, once needle body 40 has been advanced through or atleast partially through tissue fold F, needle body 40 may be released bygrasper 39 and flexible tube 38 may be retracted from tissue fold F.Suture 42 remains attached to needle body 40 and is routed through thetissue passage 43 created by needle body 40. Suture 42 may be disposedand/or anchored within or proximally of flexible tube 14 or it maysimply be ejected therefrom.

Once grasper 39 has been retracted from tissue fold F, the entireapparatus and catheter body may be rotated relative to tissue fold Fsuch that flexible tube 14 becomes aligned on the opposite side oftissue fold F, i.e., on the side of the tissue where needle body 40exits tissue fold F, as shown in FIG. 5C. In this example, rotatablegrasper 36 may keep its grasp on tissue fold F to maintain a position ofcatheter 11 relative to tissue fold F and needle body 40 while thedevice is rotated in the direction as shown by arrow 44.

As shown in FIG. 5D, once the device has been realigned, flexible tube14 may again be manipulated to bend such that distal tip 24 is alignedtransversely relative to tissue fold F. Flexible tube 38 may then beadvanced distally and grasper 39 may be actuated to receive and grasponto needle body 40. Once grasper 39 has clamped or grasped onto needlebody 40, flexible tube 38 and/or flexible tube 14 may be pulledproximally to remove needle body 40 from tissue fold F, as shown in FIG.5E. Suture 42 may be seen as passing through tissue fold F and desirablythrough the overlapped muscularis layers.

While grasper 39 maintains its hold on needle body 40, the device mayagain be rotated to realign flexible tube 14 back to the other side oftissue fold F, as shown in FIG. 5F by the direction of rotation of arrow45. Once flexible tube 14 is desirably positioned, it may again bemanipulated distally to align distal tip 24 transversely relative totissue fold F which may again be pierced by advancing needle body 40into or through tissue fold F at another location adjacent to theoriginally formed tissue passage 42. While the device and needle body 40is rotated and re-rotated relative to the tissue fold F, suture 42 maybe looped about tissue fold F any number of times in a continuous orrunning suture depending upon the desired length of suture 42 and thedesired suturing effects.

When rotated, the device may be rotated about rotatable grasper 36 as itmaintains its hold onto tissue fold F. Alternatively, rotatable grasper36 may release the tissue and the entire device may be relocated alongthe tissue wall w to another position.

To facilitate the endoscopic suturing of the tissue within the hollowbody organ, the area of interest may be visualized through a number ofmethods. For instance, a laparoscopic camera may be introduced into thearea percutaneously to provide a visual image. Alternatively,visualization of the tissue area of interest and of the tissue foldFormation and suturing procedure may be visualized endoscopically bypositioning an imager, e.g., CCD camera, optical fibers, etc., into thedistal end of catheter 11.

Alternatively, as shown in FIG. 6A, an endoscope having a sufficientlysmall-sized diameter, e.g., a gastroscope 47, may be introduced into thearea by advancing the gastroscope 47 through a scope lumen 46 definedthrough torqueable catheter 11. Gastroscope 47 may be advanced such thatits distal end extends no farther than the distal end of catheter 11 toprovide images via an imager 48, e.g., CCD camera, optical fibers, etc.In another example, the gastroscope 47 may be advanced beyond catheter11 and proximally adjacent of tissue fold F. In such a case, gastroscope47 is preferably configured to, have a manipulatable distal end portionsuch that articulation of the distal portion of the gastroscope 47 intoat least a partially retroflexed configuration is achievable. Having anoff-axis imager 48 relative to tissue fold F and catheter 11 may providefor triangulation of the image and an improved image of the tissue area.

FIG. 6B shows an alternative configuration where rather than passinggastroscope 47 within a scope lumen defined through catheter 11, anexternal scope lumen 49 may be attached along an outer surface ofcatheter 11 through a variety of methods, e.g., via a plurality of bands50. Gastroscope 47 may then be advanced through external lumen 49towards tissue fold F for imaging.

As mentioned above, multiple suture loops may be achieved using thedevices and methods above depending upon the desired suturingconfigurations. FIG. 7 shows a partial perspective view of a tissueridge which may be secured by a continuous running suture loop 51 formedentirely endoscopically. In this particular configuration, suture 42 maybe passed through multiple adjacent tissue securement passages 52, 53,54 with a continuous length of suture 42. Other endoscopic suturingconfigurations are possible and the figure is intended merely to beillustrative of one type of the running sutures which are achievable.The other suturing configurations depend merely upon the desiredsuturing effects and are not limited by the illustrations shown herein.

In yet another alternative, the needle body may be configured to carry atissue anchor within a lumen or channel within the needle body. Oneexample is shown in FIG. 8A, which shows another variation of needlebody 55 having a channel defined therein sufficiently sized to retainexpandable tissue anchor 56. Anchor 56 may have suture 42 attachedthereto and trailing proximally out from needle body 55.

Anchor 56 may comprise any number of various tissue anchors preferablydesigned for placement against a soft tissue surface. For instance,anchor 56 may comprise an expandable anchor made of a meshed materialwhich allows for reconfiguration between a low-profile deliveryconfiguration, as seen within needle body 55, and an expanded deploymentconfiguration, as seen in anchor 56′ when unconstrained by needle body55. The reconfiguration of the anchor may be effected by aself-expanding metallic alloy material, such as nitinol, or it may beeffected by a meshed polymeric material which configures into anexpanded shape against a tissue surface when suture 42 is tensioned.Other examples of various types of tissue anchors which may be utilizedare described in further detail in U.S. patent application Ser. No.10/869,472 filed Jun. 15, 2004 and U.S. patent application Ser. No.10/612,170 filed Jul. 1, 2003, both of which are incorporated herein byreference in their entirety.

An example of how such a deployable anchor may be utilized may be seenin FIGS. 8 b and 8 c. The needle body 55 may be deployed through tissuefold F in the same or similar manner as described above by formingtissue fold F and passing needle body 55 partially into or through thetissue. As seen in FIG. 813, with anchor 56 positioned within needlebody 55 and suture 42 trailing therefrom, needle body 55 may be graspedby grasping assembly 39 and pulled through the tissue. Once free, anchor56 may be ejected from needle body 55, e.g., by pulling suture 42 oractively urging anchor 56 from needle body 55 via an elongate pusher orcatheter. Anchor 56′ may then be unconstrained to expand into adeployment configuration and subsequently pulled tight against tissuefold F by tensioning suture 42. Once tensioned, suture 42 may beutilized to secure tissue fold F or to hang other objects therefrom.

Although a number of illustrative variations are described above, itwill be apparent to those skilled in the art that various changes andmodifications may be made thereto without departing from the scope ofthe invention. Any of the modifications to endoscopic suturing apparatusand methods may be done in a variety of combinations with one another,as practicable. Any of the combinations or modifications is intended tobe within the scope of this invention. It is further intended in theappended claims to cover all such changes and modifications that fallwithin the true spirit and scope of the invention.

1. A system for endoscopically suturing a region of tissue, comprising:an elongate tubular member having a proximal end, a distal end, and alength therebetween; a tissue engagement device having a flexible shaftand a distal portion extending from the tubular member distal end, thedistal portion of the tissue engagement device comprising a pair of jawsadapted to releasably engage tissue thereto, wherein the pair of jaws isrotatable about its longitudinal axis relative to the flexible shaft; adeployment tube having a distal end attached by a linkage to theflexible shaft of the tissue engagement device such that the deploymenttube is rotatable about the longitudinal axis of the pair of jaws, withthe linkage having a first end attached to the deployment tube and asecond end attached to the flexible shaft; a needle grasper movablypositioned within the deployment tube; and a needle body which defines achannel therein, wherein the needle body is removably disposed withinthe deployment tube.
 2. The system of claim 1 further comprising alength of suture depending from the needle body.
 3. The system of claim2 wherein the needle grasper is adapted to releasably hold the needlebody.
 4. The system of claim 1 further comprising an expandable tissueanchor for placement within the channel.
 5. The system of claim 1wherein the elongate tubular member comprises a flexible catheter. 6.The system of claim 1 wherein the pair of jaws comprises a grasperarticulatable via a handle located at its proximal end.
 7. The system ofclaim 1 wherein the tissue engagement device is slidably disposed withina lumen defined through the elongate tubular member.
 8. The system ofclaim 1 wherein the distal portion of the tissue engagement device isadapted to be rotated while maintaining engagement with the tissue. 9.The system of claim 1 wherein the deployment tube defines a distalportion adapted to bend relative to the elongate tubular member.
 10. Thesystem of claim 1 wherein the needle grasper is adapted to slide throughthe deployment tube while holding a needle body therein.
 11. The systemof claim 1 further comprising an imager adapted to be positionedproximally of the needle grasper.
 12. The system of claim 11 wherein theimager comprises a gastroscope.
 13. The system of claim 12 wherein theimager comprises an articulatable distal end.